Recall archive / FDA device enforcement
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 — FDA record Z-0569-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 2, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
- Reason
- One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
- Classification
- Class II
- Recalling firm
- Biomet, Inc.
- Quantity
- 10 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0569-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00889024430556; Lot Number: 3145299 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Nov 2, 2023
- Center classification date
- Dec 18, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.